Tag Archives: Eli LIlly

COVID-19: When will FDA convene a public meeting of its Antimicrobial Drugs Advisory Committee for monoclonal antibody EUA requests?

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By Daniel R. Lucey M.D., MPH, FIDSA On Oct. 7, the U.S. Food and Drug Administration received requests for Emergency Use Authorization for monoclonal antibodies from two companies (Regeneron and Eli Lilly), but has not yet announced any public meetings of its Antimicrobial Drugs Advisory Committee to advise on either general issues or specific requests […]

Paused: Eli Lilly monoclonal antibody study and J&J COVID-19 vaccine trials

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By Daniel R. Lucey M.D., MPH, FIDSA In the past 24 hours both the Johnson & Johnson Phase 3 single-dose vaccine study, and the Eli Lilly monoclonal antibody study (studies?) have been paused, and their Data-Safety Monitoring Board (DSMB) convened to evaluate safety concern(s). Johnson and Johnson (J&J)  issued a statement saying: “We have temporarily […]